Testosterone Undecanoate and Quality of Life of Men and Spouses

December 23, 2012 updated by: Meir Medical Center

Satisfaction and Quality of Life of Men and Spouses of Hypogonadal Men Treated With Injectable Testosterone Undecanoate

This study will be conducted as a prospective, single-center (multiple clinics), single-arm open phase IV study.

the study will follow hypogonadal patients, and aimed to confirm the hypothesis that testosterone undecanoate improves the patient satisfaction and quality of life, with parallel improvement in their spouses's quality of life and satisfaction. Each patient/spouse will serve as his own control.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

the study protocol will follow hypogonadal patients, who initiate treatment with testosterone undecanoate, given in accordance with the standard protocol.

Hypogonadal men eligible for treatment with testosterone undecanoate, who have not been treated with testosterone undecanoate within the last 6 months prior to enrollment, can be enrolled in the study. Patients who were treated with another testosterone formulation (eg. testosterone gel, testosterone enanthate injections) will require a 4 week wash-out period. Patients must be enrolled after the decision for treatment with testosterone undecanoate has been made.

Patients will be followed for an observation period of 28 weeks. Observations will be recorded at 3 consecutive visits, and will assess patient and spouse satisfaction and quality of life with validated questionnaires.

The study design is an intra-individual comparison. Each patient/spouse serves as his own control.

a laboratory test for total testosterone level will be required in the last visit. the need for concomitant phosphodiesterase-5 inhibitors use will also be recorded and analyzed.

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

community based population of hypogonadal men, who are eligible and choose the treatment with testosterone undecanoate

Description

Inclusion Criteria:

  • Hypogonadal patient age 40 to 80 who has newly been prescribed testosterone undecanoate.
  • The patient must be in a stable (>3 months) heterosexual relationship to be eligible for the study
  • Diagnosis of hypogonadism at the discretion of the physician, based on patient's symptoms and a laboratory evidence of T levels below 12 (symptomatic patients with borderline levels of 8.4 to 12 are also eligible for testosterone replacement therapy)
  • Wash-out of 6 months for testosterone undecanoate, 4 weeks for other testosterone formulations, before study entry.
  • Patient & spouse must be capable and willing to fill-in questionnaires to be enrolled in the study
  • Informed consent is required

Exclusion Criteria:

  • The standard contraindications and warnings of treatment with testosterone replacement therapy, and specifically testosterone undecanoate, must be followed. Contra-indications as copied from the product prescribing information are: androgen-dependent carcinoma of the prostate or of the male mammary gland; past or present liver tumors; hypersensitivity to the active substance or to any of the excipients
  • Men with desired paternity will be excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Testosterone Undecanoate
treatment with testosterone undecanoate 1000mg intramuscular, at week 0, week 6, week 18.
Drug: testosterone undecanoate
treatment with testosterone undecanoate 1000mg intramuscular, at week 0, week 6, week 18.
Other Names:
  • Nebido 1000mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient and spouse satisfaction an quality of life
Time Frame: 28 weeks
the outcome measure will be assessed with various validated questionnaires.
28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Investigators

  • Principal Investigator: uri gur, MD, Israel: Clalit Health Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

July 1, 2014

Study Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

December 23, 2012

First Submitted That Met QC Criteria

December 23, 2012

First Posted (Estimate)

December 31, 2012

Study Record Updates

Last Update Posted (Estimate)

December 31, 2012

Last Update Submitted That Met QC Criteria

December 23, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NBD01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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